The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot Thyroid Autoimmunity Panel.
| Device ID | K903843 |
| 510k Number | K903843 |
| Device Name: | IMMUNODOT THYROID AUTOIMMUNITY PANEL |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | Bryan L Kiehl |
| Correspondent | Bryan L Kiehl GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | JNL |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613745058894 | K903843 | 000 |
| 00613745058252 | K903843 | 000 |
| 00613745039121 | K903843 | 000 |